FDA.reportPublic FDA data

BioMiracle staysafe ANTIBACTERIAL HANDSoap

Manufacturer
MJM SOURCING, LLC | Panrosa Enterprises, Inc.
Effective date
2020-05-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:02

Label at a glance#

ProductBioMiracle staysafe ANTIBACTERIAL HANDSoap
Active ingredientCHLOROXYLENOL
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioMiracle staysafe ANTIBACTERIAL HAND SOAPBioMiracle staysafe ANTIBACTERIAL HAND SOAP

OTC - ACTIVE INGREDIENT SECTION

DOSAGE & ADMINISTRATION SECTION

OTC - PURPOSE SECTION

INDICATIONS & USAGE SECTION

INACTIVE INGREDIENT SECTION

OTC - DO NOT USE SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - WHEN USING SECTION

INSTRUCTIONS FOR USE SECTION

WARNINGS SECTION

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77978-525-012022-01-28C16284748780-1d6a99b39-593b-a426-e053-dadaa90af4c2Labeler : MJM SOURCING, LLC NDC : 77978-525-01 BioMiracle staysafe ANTIBACTERIAL HAND SOAP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77978-525-01BioMiracle staysafe ANTIBACTERIAL HANDSoap500 mL in 1 BOTTLE, PUMPLIQUID5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77978-525BIOMIRACLE STAYSAFE ANTIBACTERIAL HANDSOAP (CHLOROXYLENOL) LIQUID [MJM SOURCING, LLC]1Legacy NDC, 1 package rows20200528_a6ae2f54-d787-bbcc-e053-2995a90aac0b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77978-52577978-525-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
GLYCOL STEARATE0324G66D0EIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCO MONOETHANOLAMIDEC80684146DIACT
CHLOROXYLENOL0F32U78V2QACTIB
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C RED NO. 4X3W0AM1JLXIACT
SODIUM CHLORIDE451W47IQ8XIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
EDETATE DISODIUM7FLD91C86KIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a6ae27fc-b049-b7fb-e053-2995a90ab7e0a6ae2f54-d787-bbcc-e053-2995a90aac0b2020-05-27Exact identifier
spl id: a6ae27fc-b049-b7fb-e053-2995a90ab7e0
spl set id: a6ae2f54-d787-bbcc-e053-2995a90aac0b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.